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CompletedNCT01257789Updated Dec 10, 2010

Eliminating Learning Curve Related Morbidity in Fast Track Laparoscopic Roux-en-Y Gastric Bypass

An observational study in Postoperative Complications, Operative Time and Surgical Volume, sponsored by Private Hospital Moelholm. Completed at 1 site in Denmark. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-12-10.

Sponsored by Private Hospital Moelholm · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

Background: Laparoscopic Roux en Y gastric bypass (LRYGB) is associated with a significant learning curve. We report the results of a systematic training programme from a high volume bariatric center measuring the outcome by comparing the results with data from a consecutive series of 1000 fast track LRYGB.

Method: Using a stepwise training programme the RY gastric bypass operation was divided into an upper and lower procedure and subdivided into 11 well defined steps. A laparoscopic surgeon without experience in upper GI surgery was mentored by an experienced bariatric surgeon. During 6 months full time fellowship 300 operations were performed.

Results: The trainee surgeon performed 61 upper procedures, and 121 lower procedures in which the mentor surgeon did the other part of the operation. In 110 patients the trainee performed both procedures. Two percent had peri-operative complications compared to 1% of 1000 patients. All were repaired and had an uneventful recovery. Two percent had postoperative complications \< 30 days compared to 2.8% in the clinic. In the trainees series there were no leaks compared to 1% in 1000 patients. Operative time was 56/55/70 min for operation 0-100/100-200/200-300 compared with an average of 47 minutes registered in the clinic. Concerning time to discharge there was no difference between patients operated by the trainee and the standard of the clinic.

Conclusion: Using a systematic training program in laparoscopic RY gastric bypass surgery eliminates morbidity of the learning curve without affecting the volume.

02

Conditions studied

  • Postoperative Complications
  • Operative Time
  • Surgical Volume

Keywords

  • laparoscopic gastric bypass
  • learning curve
  • complications
  • operative time
03

In context

Postoperative Complications

1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.

This study's enrollment of 300 is above the median of 254 across 519 observational studies indexed under Postoperative Complications.

Browse Postoperative Complications studies →

Lead sponsor

This is the only study on the registry with Private Hospital Moelholm as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

300 consequtive patients already sceduled for laparoscopic gastric bypass surgery

Inclusion criteria

patients undergoing laparoscopic gastric bypass

Exclusion criteria

Exclusion Criteria:

  • super obesity
  • male patients
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (actual)

Groups and cohorts

  • gastric bypass patients

    Consecutive series of 300 patients undergoing laparoscopic gastric bypass

    Procedure: laparoscopic gastric bypass

Interventions

  • Procedurelaparoscopic gastric bypass

    laparoscopic gastric bypass

06

What researchers measure

Primary outcomes

  1. complication rate

    data of all postoperative complications untill 4 months post OP were collected

07

Study locations

1 site
  • Private Hospital Moelholm
    Vejle, 8900, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01257789
Lead sponsor
Private Hospital Moelholm
First posted
Dec 10, 2010
Start date
Mar 2009
Primary completion
Sep 2009
Completion
Feb 2010
Last update
Dec 10, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.

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